Registration Dossier
Registration Dossier
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EC number: 205-487-5 | CAS number: 141-52-6
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Additional information
Sodium ethanolate is classified according to Annex I to the Directive 67/548/EEC with R34 (= corrosive); GHS classification: H314 (Skin Corr. 1B) and testing regarding acute toxicity is not meaningful/necessary. Nevertheless, one oral study performed according to OECD guideline 401 is available. Here, an LD50 value of 598 mg/kg (male/female) was received. Dissection showed a dark brown to black colour of the spleens and the livers. Mucosa of the forestomach and stomach were corroded. Strong hyperemia and swelling of the gastric epithelium. Stomach, liver, spleen, pancreas, and the intestine sticked together.
Several studies are available from ethanol. Here, guideline studies were performed according to OECD 401 ( The Procter and Gamble Company, 1976 a, b; Youssef et al., 1992; Wiberg et al., 1970; Bartsch et al., 1976). The LD50 values of ethanol that were determined were mostly in the region of higher than 10000 mg/kg bw. In an acute oral toxicity study to guideline using the up and down procedure, the oral LD50 in female rats of SDA Alcohol (100% ethanol) was determined to be >7692 mg/kg bw (Kinberly et al., 1991). Based on the corrosivity of sodium ethanolate, such high ethanol concentrations will not be reached.
Two acute inhalation studies exist performed similar to guideline 403 but with extended exposure time. Here, ethanol vapour was found to be of low toxicity. The LC50 (6hr) lay between 50 -55 mg/l and the LC0 around 43-44 mg/l (BASF, 1980) and in the second study LC50 lay at 124.7 mg/L (BASF 1980 b).
In another study, mice were exposed to ethanol for up to 1 hour in order to determine the LC50 and the EC50 for motor performance. An LC50 could not be obtained for inhalation exposure; no deaths were reported for exposures up to 60,000 ppm (114 mg/l). In the motor performance test, an EC50 (60 min) value of 30,300 ppm was determined (Moser, 1985)
Based on the corrosive properties of sodium ethanolate, such high concentrations cannot be achieved.
Justification for classification or non-classification
Based on the available acute oral toxicity data for sodium ethanolate, criteria for classification are fulfilled for acute toxicity with R22 (harmful if swallowed), according to 67/548/EEC and acute tox. Cat 4, H302 according to 1272/2008/EC (CLP, GHS).
But for classification purposes, it has to be considered that sodium ethanolate is classified as skin corrosive. The acute oral toxicity is based on corrosive properties of the test substance, therefore no classification is proposed.
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